What’s up with the latest Xarelto TV commercial? That’s what the Twitterati are asking this week in a series of tweets and retweets that call out potentially misleading visuals in the Johnson & Johnson drug ad.
ProPublica Senior Editor Charles Ornstein kicked off the debate on Monday in a Twitter thread that began, “I saw this commercial for the novel anticoagulant Xarelto the other day and it seemed a bit misleading.”
The ad he was referring to started running at the end of April and features, as one of two patients, a woman named Tiffany talking about her experience with pulmonary embolism. Tiffany, clad in a leather motorcycle jacket, stands near a motorcycle while she talks about her scary experience with PE that began just after she finished a ride.
I saw this commercial for the novel anticoagulant Xarelto the other day and it seemed a bit misleading. https://t.co/cyucnPDmOK 1/x— Charles Ornstein (@charlesornstein) August 6, 2018
The issue Ornstein raised is that as the ad continues, Tiffany walks around motorcycles with friends even after a disclaimer appears on the screen noting, “As with any blood thinner, Tiffany had to stop riding her motorcycle while taking Xarelto.”
Ornstein wrote, “The disclaimer is there for a couple seconds and then the ad shows her surrounded by motorcycles again. I don’t know about you, but this seemed really misleading. And possibly dangerous.”
The next day Zachary Brennan, managing editor at RAPS' Regulatory Focus, pointed to a story he wrote in March about CSL Behring getting an FDA warning letter with the comment, “Warning was sent for a similar ad w/a soccer player picture bc hemophilic patients aren't supposed to play soccer.”
Two other reporters added they had seen similar types of ads get warning letters from the FDA. Sarah Karlin-Smith, a Politico health care reporter, retweeted Ornstein's post and added in part, “I've seen FDA give companies warning letters for similar things in ads - aka where people doing things the person on that drug or with that condition would not be able to do."
I've seen FDA give companies warning letters for similar things in ads - aka where people doing things the person on that drug or with that condition would not be able to do. was one very recently. it may come to mind shortly. https://t.co/fUyEh04fTA— Sarah Karlin-Smith (@SarahKarlin) August 7, 2018
Alison Kodjak, health policy reporter at NPR then replied to Karlin-Smith, “Mylan got in trouble for this in an Epipen ad that showed a child eating peanuts.” (While true in spirit, that’s not exactly correct; Pfizer and Mylan did get a warning letter from the FDA in 2012 over EpiPen ad in which a child going to a birthday party has an exchange with his mother about not needing to worry about a “cake made of who-knows-what” because he has his EpiPen. The advertising was pulled.)
When asked about the ad, an FDA spokeswoman said, via email, that the agency "cannot comment on a specific ad, nor communications with a specific company."
Meg Tirrell, biotech and pharma reporter for CNBC, also commented about the “interesting thread” and wondered why J&J didn’t simply feature another activity that would not be contraindicated.
J&J for its part stands by the ad. A Janssen spokeswoman said the company works closely with the OPDP to make sure the ads meet their rigorous standard and that it is important for ads to be viewed in their entirety. According to data from real-time TV ad tracker iSpot.tv, J&J has spent an estimated $24 million on that ad so far on national TV airings.
“In this particular Xarelto ad, the patient does not ride a motorcycle nor does the ad suggest that she should. Rather, it provides a flashback to when she had experienced symptoms of a pulmonary embolism – prior to beginning treatment with Xarelto,” the spokeswoman in an email. “At Janssen, we are committed to the safety of those who take our medicines. This is why we also included the following statement in our ad, ‘As with any blood thinner, Tiffany had to stop riding her motorcycle while taking Xarelto.’”